US20070297987A1 - Anti-Adhesion Sheet - Google Patents

Anti-Adhesion Sheet Download PDF

Info

Publication number
US20070297987A1
US20070297987A1 US11426464 US42646406A US2007297987A1 US 20070297987 A1 US20070297987 A1 US 20070297987A1 US 11426464 US11426464 US 11426464 US 42646406 A US42646406 A US 42646406A US 2007297987 A1 US2007297987 A1 US 2007297987A1
Authority
US
Grant status
Application
Patent type
Prior art keywords
sheet
anti
adhesion
adhesion sheet
radiopaque marker
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
US11426464
Other versions
US8709094B2 (en )
Inventor
Shawn Stad
Michael J. O'Neil
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
DePuy Synthes Products Inc
Original Assignee
DePuy Spine LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0642Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/04X-ray contrast preparations
    • A61K49/0409Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0815Implantable devices for insertion in between organs or other soft tissues
    • A61B2090/0816Implantable devices for insertion in between organs or other soft tissues for preventing adhesion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth

Abstract

An anti-adhesion sheet for placement upon the anterior wall of a vertebral body, wherein the sheet has a radius of curvature that is less than that of the anterior wall of the vertebral body.

Description

    BACKGROUND OF THE INVENTION
  • The leading cause of lower back pain arises from rupture or degeneration of lumbar intervertebral discs. Pain in the lower extremities is caused by the compression of spinal nerve roots by a bulging disc, while lower back pain is caused by collapse of the disc and by the adverse effects of articulation weight through a damaged, unstable vertebral joint. One proposed method of managing these problems is to remove the problematic disc and replace it with a prosthetic disc that allows for the natural motion between the adjacent vertebrae (“a motion disc”).
  • Surgery for the revision of an anterior lumbar motion disc, while rare, is particularly challenging due to adhesion that form following the mobilization of the great vessels during the initial procedure. The tenacity of these adhesions coupled with the fragility of the vena cava enhances the potential that this venous structure may become torn or ruptured during the revision surgery. Considering these factors and the technically demanding repair required, there is significant risk to the patient.
  • Anti-adhesion sheets have been proposed for use in both anterior motion disc implantation and anterior intervertebral fusion surgeries in order to maintain a dissection plain to the surgical site to reduce the tenacity, area and density of the adhesions. Historically, there have been many proposals for anti-adhesion devices for use in hernia repair and for the prevention of intra-abdominal adhesions. One such example of an anti-adhesion device for hernia repair is found in US Published Patent Application No. 2005/0192600. Such devices do not have to take into account the prevention of damage to great vessel walls. Anti-adhesion devices have also been used in the posterior region of the spine to prevent dural adhesions. These devices are typically described as being in the form of a gel, a thick plate or a mesh.
  • U.S. Pat. No. 6,869,938 (“Schwartz”) discloses an anti-adhesion material that is available as either a membrane or gel, specifically comprising a polyacid, a polyalkylene oxide, and a water soluble multivalent cation.
  • U.S. Pat. No. 6,475,219 (“Shelokov”) discloses an anti-adhesion barrier for use in spinal surgery, wherein the barrier has a pleat to allow stretching as a consequence of movement between vertebral bodies to which the barrier is connected. Shelokov further discloses that the anti-adhesion barrier may have a radiopaque tab to aid in locating the device once it is in a working position. Shelokov further discloses that the anti-adhesion barrier has a concave face having a radius of curvature equal to the radius of curvature of the vertebral body to which it is attached. See FIG.1 of Shelekov. Shelokov further discloses that the anti-adhesion barrier has holes for receiving bone fasteners so that the device may be secured to the vertebral bodies.
  • SUMMARY OF THE INVENTION
  • It is an object of the present invention to provide an improved anti-adhesion barrier between the vessels and the spinal column, thereby inhibiting the formation of adhesions.
  • In one embodiment, the present invention relates to an anti-adhesion sheet that includes radiographic markers to help the surgeon visualize the device.
  • Therefore, in accordance with the present invention, there is provided an anti-adhesion sheet having an interior region and an edge region encompassing the interior region, and comprising at least one radiopaque marker, wherein the radiopaque marker defines the edge region of the sheet.
  • Also in accordance with the present invention, there is provided an anti-adhesion sheet having an interior region and an edge region encompassing the interior region, and comprising at least one radiopaque marker located at least partially in an interior region of the sheet.
  • Also in accordance with the present invention, there is provided a tab-less anti-adhesion sheet having a radiopaque marker.
  • Also in accordance with the present invention, there is provided an anti-adhesion sheet having a bulk region and a tab region, wherein the bulk region comprises a radiopaque marker.
  • In a second embodiment, the present invention relates to an anti-adhesion sheet that includes features for bony purchase to help the surgeon properly place the device.
  • Therefore, in accordance with the present invention, there is provided an anti-adhesion sheet having bony purchase features selected from the group consisting of mesh, adhesive and pre-attached bone anchors.
  • In a third embodiment, the present invention relates to an anti-adhesion sheet that includes a reduced radius of curvature to help the surgeon properly conform the device to the vertebral body surface and prevent migration.
  • Therefore, in accordance with the present invention, there is provided a method comprising:
      • a) providing a vertebral body having an anterior wall defining a first radius of curvature,
      • b) providing an anti-adhesion sheet having a concave face defining a second radius of curvature, wherein the first radius of curvature is greater than the second radius of curvature, and
  • attaching the concave face of the anti-adhesion sheet to the anterior wall of the vertebral body.
  • DESCRIPTION OF THE FIGURES
  • FIGS. 1 a-1 c disclose top views of anti-adhesions sheets having radiopaque markers therein.
  • FIGS. 2 a-b disclose perspective and side views of anti-adhesion sheets having mesh strips.
  • FIGS. 2 c-d disclose perspective and side views of anti-adhesion sheets having adhesive strips.
  • FIGS. 2 e-f disclose perspective and side views of anti-adhesion sheets having pre-attached bone anchors.
  • FIG. 3 a-b discloses a perspective view of an anti-adhesion sheet having compression ridges.
  • FIGS. 4 a-4 c disclose axial views of anti-adhesions sheets having a reduced radius of curvature being attached to the anterior wall of a vertebral body.
  • FIGS. 5 a-b discloses perspective views of anti-adhesion sheets having bend zones.
  • FIGS. 6 a-b discloses top views of anti-adhesion sheets having rounded corners.
  • FIG. 7 discloses perspective views of an outer sleeve and an awl used to attach the present invention.
  • FIG. 8 is an embodiment of a staple used to attach the present invention to bony anatomy.
  • FIGS. 9 a and 9 b disclose exploded and assembled views of the inserter of the present invention.
  • FIGS. 10 a and 10 b disclose exploded and assembled views of the inserter tip of the present invention.
  • FIGS. 11 a and 11 b disclose aligned and assembled views of the inserter tip and outer sleeve of the present invention.
  • DETAILED DESCRIPTION OF THE INVENTION
  • Now referring to FIGS. 1 a-1 c, in some embodiments, the present invention relates to an anti-adhesion sheet 1 that includes radiographic markers 3 to help the surgeon visualize the device. The sheet can comprise imaging markers that will make the sheet visible when viewed by a fluoroscope, MRI or CT. In preferred embodiments, the markings can be used to indicate midline (as in FIG. 1 a), the corners of the sheet (as in FIG. 1 b), or the edge or boundaries of the sheet (as in FIG. 1 c).
  • For example, in some embodiments, the sheet has a plurality of corners, and the edge region includes a radiopaque marker located in each respective corner of the sheet In other embodiments, the radiopaque marker extends continuously along the edge region of the sheet.
  • Preferably, the radio-opacity of the sheet is created with a radiopaque material such as tungsten ink, barium sulfate, calcium sulfate, and metallic coatings.
  • In some embodiments, the sheet is dyed a particular color so that it is readily distinguishable when placed at the surgical site. This dye will make the sheet coverage apparent while enabling the surgeon to continue to see through the sheet and visualize the interbody device. Preferably, the dyed sheet remains translucent, so as to enable the surgeon to see through it as the surgeon closes. More preferably, the dyed sheet remains transparent.
  • In a second embodiment, the present invention relates to an anti-adhesion sheet that includes features for bony purchase to help the surgeon properly place the device.
  • Now referring to FIG. 2 a-b, in some embodiments, the anti-adhesion sheet 50 includes bony purchase features including mesh, such as mesh strips 51. These mesh strips allow for bony ingrowth and long term attachment. Preferably, the mesh strips are included on the concave side of the anti-adhesion sheet.
  • Now referring to FIG. 2 c-d, in some embodiments, the anti-adhesion sheet 52 has bony purchase features including an adhesive strip 53, such as a surgical glue or a pressure sensitive adhesive strip. These features enhance attachment of the anti-adhesion sheet to the bony surface. In some embodiments, a surgical glue is selected, and is preferably selected from the group consisting of fibrin glue and the cyanoacrylate family of adhesives, including Closuer's surgical sealants. In some embodiments, the pressure sensitive adhesive is selected and is, for example, bone wax. Preferably, the adhesive is included on the concave side of the anti-adhesion sheet.
  • Now referring to FIG. 2 e-f, in some embodiments, there is provided an anti-adhesion sheet 56 having bony purchase features including pre-attached bone anchors 55. The proximal ends of the bone anchors are attached to the anti-adhesion sheet in reinforced regions 57 of the anti-adhesion sheet. These reinforced regions add strength to the sheet so as to withstand the impact that occurs during attachment of the bone anchors to the vertebra. In some embodiments, the bone anchor are in-line attached as in FIG. 2 e, while in others, the bone anchors are included angle attached as in FIG. 2 f.
  • Now referring to FIG. 3 a-b, there is provided an anti-adhesion sheet 60 having a plurality of compression ridges 61. The compression ridges enhance conformance and fit of the anti-adhesion sheet to the variations in the vertebral body surface. This will enable the sheet to attain the desired stiffness without having to increase the thickness of the entire sheet. It also enables the sheet to conform easily to the space while maintaining desirable handling characteristics.
  • Also in accordance with the present invention, there is provided an anti-adhesion sheet having a stiffness enhancement feature selected from the group consisting of a compression ridge and a rib.
  • In a third embodiment, the present invention relates to an anti-adhesion sheet that includes a reduced radius of curvature to help the surgeon properly conform the device to the vertebral body surface, prevent migration, and simplify placement and fixation of the sheet. In particular, the radius of curvature of the device is less than that of the anterior wall of the vertebral body upon which the device sits. As a result, when the sheet is pressed into place, the sheet deforms and the elastic nature of the sheet helps it to grab onto the vertebral column. The reduced radius ensures that the anti-adhesion sheet covers the tissue to be protected and maintains its position. The reduced radius also enhances deployment and handling of the anti-adhesion sheet.
  • Now referring to FIG. 4 a, there is provided an anti-adhesion sheet held in position above the anterior wall of a vertebral body, wherein the anti-adhesion sheet has a radius of curvature RAA that is less than the radius of curvature of the anterior wall of the vertebral body RVB.
  • Now referring to FIG. 4 b, upon initial placement of the device upon the vertebral body, the reduced radius allows insertion of the sheet with the sheet ends sliding along the vertebral body, preventing soft tissue manipulation and damage.
  • Now referring to FIG. 4 c, the reduced radius further provides positive seating upon final placement as well as compressive force to hold it in place. Preferably, the device has a radius of curvature of between 0.5 cm and 5.0 cm.
  • The anti-adhesion device of the present invention is preferably provided in the form of a sheet having a thickness of between about 20 μm and about 400 μm.
  • The sheet may also incorporate bend zones. Now referring to FIG. 5 a, the bend zones 40 are formed by opposing recesses 41 that produce areas of reduced wall thickness to facilitate bending or crimping at a specific location. For example, a benefit may be derived from providing a bend zone axially along several locations of the curvature and thereby allow the surgeon to improve conformance of the sheet to bony structure.
  • Therefore, in accordance with the present invention, there is provided an anti-adhesion sheet having a first face and a second face producing a first thickness therebetween, wherein the first face has a recess therein to produce a bend zone having a second wall thickness, wherein the first wall thickness is greater than the second wall thickness.
  • Now referring to FIG. 5 b, the bend zones 43 are formed by offset recesses 45 that produce areas of reduced wall thickness to facilitate a more fine degree of bending or crimping at a specific location.
  • In order to increase the safety of the device in some embodiments, the anti-adhesion sheet 70 has rounded corners 71. Now referring to FIG. 6 a, there is provided a square anti-adhesion sheet having rounded corners. Now referring to FIG. 6 b, there is provided a square anti-adhesion sheet 80 having a cloverleaves 81.
  • The anti-adhesion sheet of the present invention can be either resorbable or permanent. Preferably, the anti-adhesion device is made from a material selected from the group consisting of polypropylene (non-resorbable) and polydioxanone (resorbable).
  • Some preferred materials of construction for the anti-adhesion sheet include fluoropolymers, coplymers of PVDF and HFP, silicones, PLA and PGA.
  • Preferred bioresorbable materials, which can be used to make the anti-adhesion sheets of the present invention, include bioresorbable polymers or copolymers, preferably selected from the group consisting of hydroxy acids, (particularly lactic acids and glycolic acids; caprolactone; hydroxybutyrate; dioxanone; orthoesters; orthocarbonates; and aminocarbonates). Preferred bioresorbable materials also include natural materials such as chitosan, collagen, cellulose, fibrin, hyaluronic acid; fibronectin, and mixtures thereof. However, synthetic bioresorbable materials are preferred because they can be manufactured under process specifications which insure repeatable properties.
  • Synthetic nonresorbable materials include silk, cotton, linen, nylon, polypropylene, polybutester, nylon and polyester.
  • A variety of bioabsorbable polymers can be used to make the anti-adhesion sheet of the present invention. Examples of suitable biocompatible, bioabsorbable polymers include but are not limited to polymers selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, biomolecules (i.e., biopolymers such as collagen, elastin, bioabsorbable starches, etc.), polyurethanes, and blends thereof. For the purpose of this invention aliphatic polyesters include, but are not limited to, homopolymers and copolymers of lactide (which includes lactic acid, D-,L- and meso lactide), glycolide (including glycolic acid), ε-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, δ-valerolactone, β-butyrolactone, χ-butyrolactone, ε-decalactone, hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one (including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one, 2,5-diketomorpholine, pivalolactone, χ,χ-diethylpropiolactone, ethylene carbonate, ethylene oxalate, 3-methyl-1,4-dioxane-2,5-dione, 3,3-diethyl-1,4-dioxan-2,5-dione, 6,8-dioxabicycloctane-7-one and polymer blends thereof. Poly(iminocarbonates), for the purpose of this invention, are understood to include those polymers as described by Kemnitzer and Kohn, in the Handbook of Biodegradable Polymers, edited by Domb, et. al., Hardwood Academic Press, pp. 251-272 (1997). Copoly(ether-esters), for the purpose of this invention, are understood to include those copolyester-ethers as described in the Journal of Biomaterials Research, Vol. 22, pages 993-1009, 1988 by Cohn and Younes, and in Polymer Preprints (ACS Division of Polymer Chemistry), Vol. 30(1), page 498, 1989 by Cohn (e.g. PEO/PLA). Polyalkylene oxalates, for the purpose of this invention, include those described in U.S. Pat. Nos. 4,208,511; 4,141,087; 4,130,639; 4,140,678; 4,105,034; and 4,205,399. Polyphosphazenes, co-, ter- and higher order mixed monomer-based polymers made from L-lactide, D,L-lactide, lactic acid, glycolide, glycolic acid, para-dioxanone, trimethylene carbonate and ε-caprolactone such as are described by Allcock in The Encyclopedia of Polymer Science, Vol. 13, pages 31-41, Wiley Intersciences, John Wiley & Sons, 1988 and by Vandorpe, et al in the Handbook of Biodegradable Polymers, edited by Domb, et al, Hardwood Academic Press, pp. 161-182 (1997). Polyanhydrides include those derived from diacids of the form HOOC—C6H4—O—(CH2)m—O—C6H4—COOH, where m is an integer in the range of from 2 to 8, and copolymers thereof with aliphatic alpha-omega diacids of up to 12 carbons. Polyoxaesters, polyoxaamides and polyoxaesters containing amines and/or amido groups are described in one or more of the following U.S. Pat. Nos. 5,464,929; 5,595,751; 5,597,579; 5,607,687; 5,618,552; 5,620,698; 5,645,850; 5,648,088; 5,698,213; 5,700,583; and 5,859,150. Polyorthoesters such as those described by Heller in Handbook of Biodegradable Polymers, edited by Domb, et al, Hardwood Academic Press, pp. 99-118 (1997).
  • Preferably, the bioresorbable material is selected from the group consisting of poly(lactic acid) (“PLA”) and poly(glycolic acid)(“PGA”), and copolymers thereof. In some of the preferred embodiments, one of the resorbable sutures is selected from the group consisting of PLA, PGA, polydioxanone (PDO), polycaprolactone (PCL), and mixtures thereof.
  • The anti-adhesion device of the present invention is preferably used in conjunction with anteriorly-placed interbody devices, such as motion discs and fusion cages.
  • One preferred method of attaching the adhesion reduction sheet to the anatomy is as follows:
  • First, following implantation of the interbody device, the surgeon manually places (or places with the help of instruments) the anti-adhesion sheet over the surgical site. At this time, the surgeon can cut the sheet to accommodate adjacent anatomy if necessary.
  • Once the anti-adhesion sheet is in place, the surgeon will place the distal end of the outer sleeve against the sheet. Now referring to FIG. 7, the outer sleeve 101 comprises:
      • a) a tube 102 extending substantially through the entire length of the tool and forming an inner bore and an outer surface 103,
      • b) a proximal end 105 comprising a hand grip 107,
      • c) a notch 109 extending from the outer surface and located just distal of the handgrip (and used to illustrate orientation of the staple),
      • d) a groove or slit 111 in the outer surface of the tube extending substantially through the entire length of the tool, and
      • e) a distal end portion 113 having two prongs 115 extending axially therefrom and adapted to advance through the anti-adhesion sheet and enter the vertebral body (thereby preventing the instrument and sheet from slipping during placement of an attachment mechanism).
  • Next, an awl is used to make holes in the vertebral body for placement of the staple. Still referring to FIG. 7, the awl 121 comprises:
      • a) an elongated shaft 122 having an outer surface 123 having a distal end portion 124,
      • b) a proximal handle 125 having a polymeric impaction surface 127,
      • c) a post 129 extending radially from the distal end portion of the outer surface of the shaft (and adapted to ride the groove of the outer sleeve during insertion in order to maintain the awl's orientation),
      • d) a pair of prongs 131 extending axially from the distal end of the shaft and adapted to puncture cortical bone.
  • The awl is delivered down the tube of the outer sleeve and is proximally impacted to make holes in the vertebral body required for fixing the prongs of the attachment mechanism (here, depicted as a staple) in the vertebral body. Once the holes are made, the awl is carefully removed from the outer sleeve while maintaining the position of the outer sleeve.
  • If a staple is selected as the attachment mechanism, then the Graft Fixation Device, available from DePuy Mitek of Raynham, Mass. may be used. One such staple is shown in FIG. 8. Similar staples made in accordance with U.S. Pat. Nos. 6,423,07; 6,436,110; 6,402,766; 6,179,840; 6,364,884; and 6,497,707, and US Published Patent Application Nos. 2002/0095157; 2002/0169465; 2002/0052628; and 2004/0138664 may be used as well.
  • After the appropriate staple is selected, it is loaded onto an inserter. In some embodiments, and now referring to FIGS. 9 a and 9 b, the inserter 151 includes:
      • a) an elongated shaft 153 having a threaded distal end 154,
      • b) a proximal handle 155 having a threadable endcap 157 adapted for impaction, and
      • c) a distal inserter tip 159.
    Now referring to FIG. 10a and 10 b, in some embodiments, the distal inserter tip 159 has
      • a) a threaded proximal end 161 for threadable reception on the threaded distal end of the shaft,
      • b) an intermediate section 163 having a radially extending orientation post 165, and
      • c) a distal end 166 having a pair of staple retention ports 167 extending axially therefrom.
    As shown in FIG. 11a, the inserter is passed through the barrel of the outer sleeve to form the assembly shown in FIG. 11b.
  • Next, impacted into place by impacting the proximal end of the inserter. Once the staple is completely seated, the entire instrument can be removed.
  • An awl is used in the above procedure because, in some embodiments, the attachment mechanism is a resorbable staple that may not have the structural strength necessary to puncture cortical bone. A resorbable attachment mechanism is typically used with a resorbable sheet. However, if a non-resorbable sheet is being used, a permanent attachment mechanism or staple may also be used. Selection of a permanent attachment mechanism or staple increases the number of materials that could be used for the attachment mechanism or staple. Stronger staple materials could eliminate the need for using the awl prior to staple placement.

Claims (20)

  1. 1. An anti-adhesion sheet having an interior region and an edge region encompassing the interior region, and comprising at least one radiopaque marker, wherein the radiopaque marker defines the edge region of the sheet.
  2. 2. The sheet of claim 1 wherein the sheet has a plurality of corners, and wherein the edge region includes a radiopaque marker located in each respective corner of the sheet.
  3. 3. The sheet of claim 1 wherein the radiopaque marker extends continuously along the edge region of the sheet.
  4. 4. An anti-adhesion sheet having an interior region and an edge region encompassing the interior region, and comprising at least one radiopaque marker located at least partially in an interior region of the sheet.
  5. 5. The sheet of claim 4 wherein the marker is located along a midline of the sheet.
  6. 6. The sheet of claim 4 wherein the marker is located continuously along a midline of the sheet.
  7. 7. A tab-less anti-adhesion sheet having a radiopaque marker.
  8. 8. An anti-adhesion sheet having a bulk region and a tab region, wherein the bulk region comprises a radiopaque marker.
  9. 9. An anti-adhesion sheet having a first face and a second face producing a first thickness therebetween, wherein the first face has a recess therein to produce a bend zone having a second wall thickness, wherein the first wall thickness is greater than the second wall thickness.
  10. 10. An anti-adhesion sheet having a stiffness enhancement feature selected from the group consisting of a compression ridge and a rib.
  11. 11. A method comprising:
    a) providing a vertebral body having an anterior wall defining a first radius of curvature,
    b) providing an anti-adhesion sheet having a concave face defining a second radius of curvature, wherein the first radius of curvature is greater than the second radius of curvature, and
    c) attaching the concave face of the anti-adhesion sheet to the anterior wall of the vertebral body.
  12. 12. An anti-adhesion sheet comprising a dye.
  13. 13. The sheet of claim 12 wherein the sheet is translucent.
  14. 14. The sheet of claim 12 wherein the sheet is transparent.
  15. 15. An anti-adhesion sheet having bony purchase features selected from the group consisting of mesh, adhesive and pre-attached bone anchors.
  16. 16. The anti-adhesion sheet of claim 15 wherein the bony purchase feature is a mesh.
  17. 17. The anti-adhesion sheet of claim 15 wherein the bony purchase feature is an adhesive.
  18. 18. The anti-adhesion sheet of claim 15 wherein the bony purchase feature is a pre-attached bone anchor.
  19. 19. The anti-adhesion sheet of claim 18 wherein the pre-attached bone anchor is in-line attached.
  20. 20. The anti-adhesion sheet of claim 18 wherein the pre-attached bone anchor is included angle.
US11426464 2006-06-26 2006-06-26 Anti-adhesion sheet Active 2027-05-20 US8709094B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11426464 US8709094B2 (en) 2006-06-26 2006-06-26 Anti-adhesion sheet

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11426464 US8709094B2 (en) 2006-06-26 2006-06-26 Anti-adhesion sheet
PCT/US2007/071730 WO2008002815A3 (en) 2006-06-26 2007-06-21 Anti-adhesion sheet

Publications (2)

Publication Number Publication Date
US20070297987A1 true true US20070297987A1 (en) 2007-12-27
US8709094B2 US8709094B2 (en) 2014-04-29

Family

ID=38846421

Family Applications (1)

Application Number Title Priority Date Filing Date
US11426464 Active 2027-05-20 US8709094B2 (en) 2006-06-26 2006-06-26 Anti-adhesion sheet

Country Status (2)

Country Link
US (1) US8709094B2 (en)
WO (1) WO2008002815A3 (en)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080119851A1 (en) * 2006-11-20 2008-05-22 Depuy Spine, Inc. Anterior spinal vessel protector
US20080300595A1 (en) * 2007-06-04 2008-12-04 Brau Salvador A Encasement prevention barrier for use in anterior lumbar surgery
US20090192532A1 (en) * 2007-12-03 2009-07-30 Linda Spinnler Implant for parastomal hernia
US20140200667A1 (en) * 2013-01-15 2014-07-17 Tepha, Inc. Implants for Soft and Hard Tissue Regeneration
US9526603B2 (en) 2011-09-30 2016-12-27 Covidien Lp Reversible stiffening of light weight mesh
US9877820B2 (en) 2014-09-29 2018-01-30 Sofradim Production Textile-based prosthesis for treatment of inguinal hernia
US9932695B2 (en) 2014-12-05 2018-04-03 Sofradim Production Prosthetic porous knit

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9242026B2 (en) 2008-06-27 2016-01-26 Sofradim Production Biosynthetic implant for soft tissue repair
DE102008059245A1 (en) * 2008-11-20 2010-05-27 Aesculap Ag Areal implant, in particular for sealing liquid and / or air leaks in the human and / or animal body, and method for its preparation
FR2972626B1 (en) 2011-03-16 2014-04-11 Sofradim Production Prosthesis comprising a knitted spacer fabric and openwork
FR2977789B1 (en) 2011-07-13 2013-07-19 Sofradim Production Prosthesis for umbilical hernia
FR2977790B1 (en) 2011-07-13 2013-07-19 Sofradim Production Prosthesis for umbilical hernia
FR2985170B1 (en) 2011-12-29 2014-01-24 Sofradim Production Prosthesis for inguinal hernia
FR2985271B1 (en) 2011-12-29 2014-01-24 Sofradim Production Tricot pins
US20130261542A1 (en) * 2012-03-30 2013-10-03 Covidien Lp Implantable Devices Including A Film Providing Folding Characteristics
FR2995788B1 (en) 2012-09-25 2014-09-26 Sofradim Production Hemostatic patch and method of preparation
FR2995778B1 (en) 2012-09-25 2015-06-26 Sofradim Production reinforcement prosthesis of the abdominal wall and method of manufacture
FR2995779B1 (en) 2012-09-25 2015-09-25 Sofradim Production Prothese including a mesh and a consolidation means
EP3085337A1 (en) 2015-04-24 2016-10-26 Sofradim Production Prosthesis for supporting a breast structure
US20180280156A1 (en) * 2017-04-04 2018-10-04 Robert B. Dzioba Mobile cage system for restoring motion kinematics of the spine

Citations (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4105034A (en) * 1977-06-10 1978-08-08 Ethicon, Inc. Poly(alkylene oxalate) absorbable coating for sutures
US4130639A (en) * 1977-09-28 1978-12-19 Ethicon, Inc. Absorbable pharmaceutical compositions based on isomorphic copolyoxalates
US4140678A (en) * 1977-06-13 1979-02-20 Ethicon, Inc. Synthetic absorbable surgical devices of poly(alkylene oxalates)
US4141087A (en) * 1977-01-19 1979-02-27 Ethicon, Inc. Isomorphic copolyoxalates and sutures thereof
US4205399A (en) * 1977-06-13 1980-06-03 Ethicon, Inc. Synthetic absorbable surgical devices of poly(alkylene oxalates)
US4208511A (en) * 1977-01-19 1980-06-17 Ethicon, Inc. Isomorphic copolyoxalates and sutures thereof
US5071823A (en) * 1988-10-12 1991-12-10 Mitsubishi Paper Mills Limited Image-receiving sheet for transfer recording
US5464929A (en) * 1995-03-06 1995-11-07 Ethicon, Inc. Absorbable polyoxaesters
US5593441A (en) * 1992-03-04 1997-01-14 C. R. Bard, Inc. Method for limiting the incidence of postoperative adhesions
US5595751A (en) * 1995-03-06 1997-01-21 Ethicon, Inc. Absorbable polyoxaesters containing amines and/or amido groups
US5597579A (en) * 1995-03-06 1997-01-28 Ethicon, Inc. Blends of absorbable polyoxaamides
US5607687A (en) * 1995-03-06 1997-03-04 Ethicon, Inc. Polymer blends containing absorbable polyoxaesters
US5618552A (en) * 1995-03-06 1997-04-08 Ethicon, Inc. Absorbable polyoxaesters
US5620698A (en) * 1995-03-06 1997-04-15 Ethicon, Inc. Blends of absorbable polyoxaesters containing amines and/or amido groups
US5698213A (en) * 1995-03-06 1997-12-16 Ethicon, Inc. Hydrogels of absorbable polyoxaesters
US5700583A (en) * 1995-03-06 1997-12-23 Ethicon, Inc. Hydrogels of absorbable polyoxaesters containing amines or amido groups
US5792128A (en) * 1995-10-05 1998-08-11 Deroyal Industries, Inc. Absorbent article having a radiopaque element embedded in a side edge thereof and method for making same
US5859150A (en) * 1995-03-06 1999-01-12 Ethicon, Inc. Prepolymers of absorbable polyoxaesters
US5891824A (en) * 1996-12-17 1999-04-06 Eastman Kodak Company Transparent protective sheet for thermal dye transfer print
US6179840B1 (en) * 1999-07-23 2001-01-30 Ethicon, Inc. Graft fixation device and method
US6364884B1 (en) * 1999-07-23 2002-04-02 Ethicon, Inc. Method of securing a graft using a graft fixation device
US20020052628A1 (en) * 1999-07-23 2002-05-02 Bowman Steven M. Graft fixation device and method
US6402766B2 (en) * 1999-07-23 2002-06-11 Ethicon, Inc. Graft fixation device combination
US20020095157A1 (en) * 1999-07-23 2002-07-18 Bowman Steven M. Graft fixation device combination
US20020095205A1 (en) * 2001-01-12 2002-07-18 Edwin Tarun J. Encapsulated radiopaque markers
US6423073B2 (en) * 1999-07-23 2002-07-23 Ethicon, Inc. Instrument for inserting graft fixation device
US6436110B2 (en) * 1999-07-23 2002-08-20 Ethicon, Inc. Method of securing a graft using a graft fixation device
US6468928B2 (en) * 1998-05-29 2002-10-22 Benecke-Kaliko Ag Translucent sheets
US6475219B1 (en) * 2001-06-07 2002-11-05 Alexis P. Shelokov Anterior vertebral protection method and device
US20020169465A1 (en) * 1999-07-23 2002-11-14 Bowman Steven M. Graft fixation device
US6482491B1 (en) * 1998-01-30 2002-11-19 Coloplast A/S Article having a surface showing adhesive properties
US6497707B1 (en) * 1999-07-23 2002-12-24 Ethicon, Inc. Graft fixation device combination
US20040018228A1 (en) * 2000-11-06 2004-01-29 Afmedica, Inc. Compositions and methods for reducing scar tissue formation
US6869938B1 (en) * 1997-06-17 2005-03-22 Fziomed, Inc. Compositions of polyacids and polyethers and methods for their use in reducing adhesions
US20050192600A1 (en) * 2004-02-24 2005-09-01 Enrico Nicolo Inguinal hernia repair prosthetic
US20050192699A1 (en) * 2004-02-26 2005-09-01 Taiwan Semiconductor Manufacturing Co., Ltd. Temperature-sensing wafer position detection system and method
US20050228491A1 (en) * 2004-04-12 2005-10-13 Snyder Alan J Anti-adhesive surface treatments
US7758654B2 (en) * 2004-05-20 2010-07-20 Kensey Nash Corporation Anti-adhesion device
US7767222B2 (en) * 2002-07-31 2010-08-03 Mast Biosurgery Ag Apparatus and method for preventing adhesions between an implant and surrounding tissues

Patent Citations (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4141087A (en) * 1977-01-19 1979-02-27 Ethicon, Inc. Isomorphic copolyoxalates and sutures thereof
US4208511A (en) * 1977-01-19 1980-06-17 Ethicon, Inc. Isomorphic copolyoxalates and sutures thereof
US4105034A (en) * 1977-06-10 1978-08-08 Ethicon, Inc. Poly(alkylene oxalate) absorbable coating for sutures
US4140678A (en) * 1977-06-13 1979-02-20 Ethicon, Inc. Synthetic absorbable surgical devices of poly(alkylene oxalates)
US4205399A (en) * 1977-06-13 1980-06-03 Ethicon, Inc. Synthetic absorbable surgical devices of poly(alkylene oxalates)
US4130639A (en) * 1977-09-28 1978-12-19 Ethicon, Inc. Absorbable pharmaceutical compositions based on isomorphic copolyoxalates
US5071823A (en) * 1988-10-12 1991-12-10 Mitsubishi Paper Mills Limited Image-receiving sheet for transfer recording
US5593441A (en) * 1992-03-04 1997-01-14 C. R. Bard, Inc. Method for limiting the incidence of postoperative adhesions
US5607687A (en) * 1995-03-06 1997-03-04 Ethicon, Inc. Polymer blends containing absorbable polyoxaesters
US5595751A (en) * 1995-03-06 1997-01-21 Ethicon, Inc. Absorbable polyoxaesters containing amines and/or amido groups
US5597579A (en) * 1995-03-06 1997-01-28 Ethicon, Inc. Blends of absorbable polyoxaamides
US5464929A (en) * 1995-03-06 1995-11-07 Ethicon, Inc. Absorbable polyoxaesters
US5618552A (en) * 1995-03-06 1997-04-08 Ethicon, Inc. Absorbable polyoxaesters
US5620698A (en) * 1995-03-06 1997-04-15 Ethicon, Inc. Blends of absorbable polyoxaesters containing amines and/or amido groups
US5645850A (en) * 1995-03-06 1997-07-08 Ethicon, Inc. Blending containing absorbable polyoxaamides
US5648088A (en) * 1995-03-06 1997-07-15 Ethicon, Inc. Blends of absorbable polyoxaesters containing amines and/or amide groups
US5698213A (en) * 1995-03-06 1997-12-16 Ethicon, Inc. Hydrogels of absorbable polyoxaesters
US5700583A (en) * 1995-03-06 1997-12-23 Ethicon, Inc. Hydrogels of absorbable polyoxaesters containing amines or amido groups
US5859150A (en) * 1995-03-06 1999-01-12 Ethicon, Inc. Prepolymers of absorbable polyoxaesters
US5792128A (en) * 1995-10-05 1998-08-11 Deroyal Industries, Inc. Absorbent article having a radiopaque element embedded in a side edge thereof and method for making same
US5891824A (en) * 1996-12-17 1999-04-06 Eastman Kodak Company Transparent protective sheet for thermal dye transfer print
US6869938B1 (en) * 1997-06-17 2005-03-22 Fziomed, Inc. Compositions of polyacids and polyethers and methods for their use in reducing adhesions
US6482491B1 (en) * 1998-01-30 2002-11-19 Coloplast A/S Article having a surface showing adhesive properties
US6468928B2 (en) * 1998-05-29 2002-10-22 Benecke-Kaliko Ag Translucent sheets
US6402766B2 (en) * 1999-07-23 2002-06-11 Ethicon, Inc. Graft fixation device combination
US20020095157A1 (en) * 1999-07-23 2002-07-18 Bowman Steven M. Graft fixation device combination
US6364884B1 (en) * 1999-07-23 2002-04-02 Ethicon, Inc. Method of securing a graft using a graft fixation device
US6423073B2 (en) * 1999-07-23 2002-07-23 Ethicon, Inc. Instrument for inserting graft fixation device
US6436110B2 (en) * 1999-07-23 2002-08-20 Ethicon, Inc. Method of securing a graft using a graft fixation device
US20020052628A1 (en) * 1999-07-23 2002-05-02 Bowman Steven M. Graft fixation device and method
US20040138664A1 (en) * 1999-07-23 2004-07-15 Bowman Steven M. Graft fixation device combination
US6497707B1 (en) * 1999-07-23 2002-12-24 Ethicon, Inc. Graft fixation device combination
US6179840B1 (en) * 1999-07-23 2001-01-30 Ethicon, Inc. Graft fixation device and method
US20020169465A1 (en) * 1999-07-23 2002-11-14 Bowman Steven M. Graft fixation device
US20040018228A1 (en) * 2000-11-06 2004-01-29 Afmedica, Inc. Compositions and methods for reducing scar tissue formation
US20020095205A1 (en) * 2001-01-12 2002-07-18 Edwin Tarun J. Encapsulated radiopaque markers
US6475219B1 (en) * 2001-06-07 2002-11-05 Alexis P. Shelokov Anterior vertebral protection method and device
US7767222B2 (en) * 2002-07-31 2010-08-03 Mast Biosurgery Ag Apparatus and method for preventing adhesions between an implant and surrounding tissues
US20050192600A1 (en) * 2004-02-24 2005-09-01 Enrico Nicolo Inguinal hernia repair prosthetic
US20050192699A1 (en) * 2004-02-26 2005-09-01 Taiwan Semiconductor Manufacturing Co., Ltd. Temperature-sensing wafer position detection system and method
US20050228491A1 (en) * 2004-04-12 2005-10-13 Snyder Alan J Anti-adhesive surface treatments
US7758654B2 (en) * 2004-05-20 2010-07-20 Kensey Nash Corporation Anti-adhesion device

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080119851A1 (en) * 2006-11-20 2008-05-22 Depuy Spine, Inc. Anterior spinal vessel protector
US8114159B2 (en) 2006-11-20 2012-02-14 Depuy Spine, Inc. Anterior spinal vessel protector
US8734517B2 (en) 2006-11-20 2014-05-27 DePuy Synthes Products, LLP Medical procedure involving protective pad
US20080300595A1 (en) * 2007-06-04 2008-12-04 Brau Salvador A Encasement prevention barrier for use in anterior lumbar surgery
US8157819B2 (en) 2007-06-04 2012-04-17 Brau Salvador A Encasement prevention barrier for use in anterior lumbar surgery
US20090192532A1 (en) * 2007-12-03 2009-07-30 Linda Spinnler Implant for parastomal hernia
US9308068B2 (en) * 2007-12-03 2016-04-12 Sofradim Production Implant for parastomal hernia
US9526603B2 (en) 2011-09-30 2016-12-27 Covidien Lp Reversible stiffening of light weight mesh
US20140200667A1 (en) * 2013-01-15 2014-07-17 Tepha, Inc. Implants for Soft and Hard Tissue Regeneration
US9877820B2 (en) 2014-09-29 2018-01-30 Sofradim Production Textile-based prosthesis for treatment of inguinal hernia
US9932695B2 (en) 2014-12-05 2018-04-03 Sofradim Production Prosthetic porous knit

Also Published As

Publication number Publication date Type
WO2008002815A3 (en) 2008-09-25 application
US8709094B2 (en) 2014-04-29 grant
WO2008002815A2 (en) 2008-01-03 application

Similar Documents

Publication Publication Date Title
US6579291B1 (en) Devices and methods for the treatment of spinal disorders
US7094258B2 (en) Methods of reinforcing an annulus fibrosis
US7918891B1 (en) Systems and methods for spinal fusion
US7232463B2 (en) Intervertebral cage designs
US6468309B1 (en) Method and apparatus for stabilizing adjacent bones
US6837905B1 (en) Spinal vertebral fusion implant and method
US8268000B2 (en) Composite interbody spacer
US5236431A (en) Resorbable fixation device with controlled stiffness for treating bodily material in vivo and introducer therefor
US6773437B2 (en) Shape memory alloy staple
US7335207B1 (en) Minimally invasive cup impactor
US20120078371A1 (en) Fusion cage with in-line single piece fixation
US7972382B2 (en) Minimally invasive spinal distraction devices and methods
US20120078373A1 (en) Stand alone intervertebral fusion device
US5984927A (en) Device for sutureless attachment of soft tissue to bone
US20090299479A1 (en) Suture guided implant
US7229441B2 (en) Flexible systems for spinal stabilization and fixation
US5545180A (en) Umbrella-shaped suture anchor device with actuating ring member
US20070239278A1 (en) Intervertebral prosthetic devices and methods
US7217279B2 (en) Suture loop anchor
US20050055097A1 (en) Minimally invasive modular support implant device and method
US20110166656A1 (en) Spinal implant configured for midline insertion
US20080195145A1 (en) Tissue fixation system and method
US20090018524A1 (en) Expandable delivery device
US20020055737A1 (en) Apparatus for implantation into bone related applications
US7211088B2 (en) Bioabsorbable tissue tack with oval-shaped head and method of tissue fixation using the same

Legal Events

Date Code Title Description
AS Assignment

Owner name: DEPUY SPINE, INC., MASSACHUSETTS

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:STAD, SHAWN;O'NEIL, MICHAEL J;REEL/FRAME:017844/0926

Effective date: 20060626

AS Assignment

Owner name: DEPUY SPINE, LLC, MASSACHUSETTS

Free format text: CHANGE OF NAME;ASSIGNOR:DEPUY SPINE, INC.;REEL/FRAME:030352/0673

Effective date: 20121230

Owner name: DEPUY SYNTHES PRODUCTS, LLC, MASSACHUSETTS

Free format text: CHANGE OF NAME;ASSIGNOR:HAND INNOVATIONS LLC;REEL/FRAME:030352/0722

Effective date: 20121231

Owner name: HAND INNOVATIONS LLC, FLORIDA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:DEPUY SPINE, LLC;REEL/FRAME:030352/0709

Effective date: 20121230

MAFP

Free format text: PAYMENT OF MAINTENANCE FEE, 4TH YEAR, LARGE ENTITY (ORIGINAL EVENT CODE: M1551)

Year of fee payment: 4